Siemens Healthcare Diagnostics Inc. (manufacturer, E Walpole, MA): 5 new FDA device listings, incl. test, prostate specific antigen, free, (noncomplexed) to distinguish p
Siemens Healthcare Diagnostics Inc. (E Walpole, Massachusetts): 5 new FDA device listings, incl. test, prostate specific antigen, free, (noncomplexed) to distinguish p. Its amount of 5 is above the median of 1 (87th percentile). Dated 69 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 69 related MA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Diagnostics Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | E Walpole, MA, US |
| New listings | 5 |
| Devices | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Carcinoembryonic Antigen; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Product codes | MTG, NIG, JJX, DHX, LTK |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Immunology, Clinical Chemistry |
| Brand names | Atellica IM free PSA II (fPSAII); Atellica IM CA 19-9 II (CA 19-9 II); ADVIA Centaur Carcinoembryonic Antigen (CEA); Atellica IM Carcinoembryonic Antigen (CEA); Atellica IM CA 125II (CA 125II); ADVIA Centaur CA 125II (CA 125II) |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 1219913 |
| Registration expires | 2026-12-31 |
| amount percentile | 87th of 2,570 (median 1, 5.0x median) |
| Peer records CSV (70 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-27
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Siemens Healthcare Diagnostics Inc. and 70 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 70
- Siemens Healthcare Diagnostics Inc.'s amount: 87th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Siemens Healthcare Diagnostics Inc. in E Walpole, Massachusetts?
Siemens Healthcare Diagnostics Inc. (E Walpole, MA), a manufacturer, added 5 FDA device listings between 2026-05-19 and 2026-08-27.
How does Siemens Healthcare Diagnostics Inc. compare to other Massachusetts DeviceEstablishmentPulse records?
Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 69 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Siemens Healthcare Diagnostics Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA | 5 | 87th | 2026-08-27 | This record |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA | 6 | 88th | 2026-10-16 | Compare Siemens Healthcare Diagnostics Inc. vs Boston Scientific Corp., Marina Bay Cust. Fulfillment Center → |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 | View record → |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.